104408 Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Rules and Regulations 

Authority: 49 U.S.C. 106(f), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order JO 7400.11J, 

Airspace Designations and Reporting 

Points, dated July 31, 2024, and 

effective September 15, 2024, is 

amended as follows: 

Paragraph 5000 Class D Airspace. 

* * * * * 

ANM CO D Denver, CO [Amended] 

Centennial Airport, CO 

(Lat. 39°34′12′′ N, long. 104°50′57′′ W) 

That airspace extending upward from the 

surface to but not including 8,000 feet MSL 

within 3.9 miles northwest and 4.6 miles 

southeast of the airport’s 038° bearing 

extending to 4.6 miles northeast, within a 

6.4-mile radius from the airport’s 083° 

bearing clockwise to the 201° bearing, and 

within a 4.9-mile radius from the airport’s 

201° bearing clockwise to the 347° bearing. 

* * * * * 

Paragraph 6004 Class E Airspace 

Designated as an Extension to a Class D or 

Class E Surface Area. 

* * * * * 

ANM CO E4 Englewood, CO [Removed] 

* * * * * 

Issued in Des Moines, Washington, on 

December 17, 2024. 

B.G. Chew, 

Group Manager, Operations Support Group, 

Western Service Center. 

[FR Doc. 2024–30530 Filed 12–20–24; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Parts 742 and 774 

[Docket No. 241212–0324] 

RIN 0694–AJ83 

Implementation of Certain Australia 

Group Decisions 

AGENCY: Bureau of Industry and 

Security, Department of Commerce. 

ACTION: Final rule. 

SUMMARY: The Bureau of Industry and 

Security (BIS) is amending the Export 

Administration Regulations (EAR) to 

implement changes agreed to by 

Australia Group (AG) member countries 

at recent meetings. These include 

controlling: instruments for the 

automated chemical synthesis of 

peptides (automated peptide 

synthesizers), dipropylamine, and 

neosaxitoxin; and revising the controls 

for botulinum toxins, toxic gas 

monitors, and centrifugal separators. 

This rule also makes minor conforming 

changes for the new controls and 

revisions to existing controls. 

DATES: This rule is effective December 

23, 2024. 

FOR FURTHER INFORMATION CONTACT: 

For questions on pathogens and 

toxins discussed in this rule, contact Dr. 

Lauren Reynolds, Chemical and 

Biological Controls Division, Office of 

Nonproliferation and Foreign Policy 

Controls, Bureau of Industry and 

Security, Telephone: (202) 482–2794, 

Email: Lauren.Reynolds@bis.doc.gov. 

For all other questions pertaining to 

this rule, contact Logan Norton, 

Regulatory Policy Division, Office of 

Exporter Services, Bureau of Industry 

and Security, U.S. Department of 

Commerce, (202) 482–1762, Email: 

RPD2@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

The Australia Group 

BIS is amending the Export 

Administration Regulations (EAR) (15 

CFR parts 730–774) to reflect the 

decisions made at the 2023 

Intersessional Meeting in Rome, Italy, 

the 2023 Plenary Meeting in Paris, 

France, the 2024 Intersessional Meeting 

in Berlin, Germany and the 2024 

Plenary Meeting in Paris, France. The 

Australia Group (AG) is a multilateral 

forum consisting of 42 participating 

countries and the European Union. 

These participants maintain export 

controls on a list of chemicals, 

biological agents, and related equipment 

and technology that could be used in a 

chemical or biological weapons 

program. The AG periodically reviews 

items on its control list to enhance the 

effectiveness of participating 

governments’ national controls and to 

achieve greater harmonization among 

these controls. 

Regulatory Changes 

As stated above, this rule implements 

changes agreed upon at the 2023 and 

2024 Intersessional and Plenary 

Meetings of the AG. The changes made 

at each meeting are described below in 

chronological order. 

2023 Intersessional 

The AG meeting of the 2023 

Intersessional determined that not all 

AG members assess gas detection 

systems with the same criteria. Prior to 

this rule, the control text only referred 

to the ability to detect chemical warfare 

agents or AG controlled precursors at a 

concentration of less than 0.3 mg/m3. 

This made it unclear if a gas detection 

system with a noise level near 0.3 mg/ 

m3 was controlled, without taking into 

account the instrument detection limit. 

As a result, the AG agreed to a uniform 

way of applying the control language on 

toxic gas monitors and monitoring 

systems. To clarify the text, the AG 

agreed to the new term called ‘minimum 

detection limit’ and a corresponding 

definition, both detailed below, to the 

control text. 

The AG agreed to two changes to 

ECCN 2B351. First, in item paragraph .a, 

‘‘at concentrations of less than’’ is 

replaced with ‘‘‘minimum detection 

limit’ of’’, which is still followed by the 

0.3 mg/m3 concentration measurement. 

Second, it adds a technical note 

defining ‘minimum detection limit’ as 

the lowest detectable concentration of 

the analyte required to produce a signal 

greater than three times the standard 

deviation of the toxic gas monitor’s or 

monitoring system’s signal when 

measuring a blank sample; alternatively, 

in the case of toxic gas monitors or 

monitoring systems having a deadband 

or programmed zero suppression, the 

‘minimum detection limit’ is the lowest 

detectable concentration required to 

produce a reading. 

2023 Plenary 

In the 2023 Plenary Meeting, the AG 

reached consensus on three primary 

revisions, mostly impacting ECCNs 

1C350.d and 1C351.d. 

ECCN 1C350.d had multiple changes. 

In February 2020 the AG added a 

number of precursors to the chemical 

weapons precursors control list. 

However, dipropylamine, which is also 

useful for the synthesis of the 

corresponding AG-controlled 

precursors, was not yet controlled. The 

AG determined that it was important to 

address this issue by controlling 

dipropylamine. Under ECCN 1C350, 

(C.A.S. #142–84–7) Dipropylamine was 

added as .d.11. The items that had been 

listed in item paragraphs .d.11 through 

.d.49 remain, with their item paragraphs 

shifting up by a factor of one. 

Botulinum toxins can be neurotoxins 

or non-neurotoxins. Previously, the AG 

had not specifically stated if only 

botulinum neurotoxins should be 

captured by ECCN 1C351.d.3 or if all 

botulinum toxins are included. The AG 

agreed to update the language to 

‘‘botulinum neurotoxins’’ noting the 

greater risk of their use in chemical and 

biological weapons activities relative to 

other botulinum toxins. Under ECCN 

1C351, item paragraph .d.3 was revised 

to read as ‘‘botulinum neurotoxins’’ as 

opposed to previously reading 

‘‘botulinum toxins.’’ Conforming 


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Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Rules and Regulations 104409 

1Sameer S. Kulkarni et al., Rapid and Efficient 

Protein Synthesis Through Expansion of the Native 

Chemical Ligation Concept, Nature Revs. 

Chemistry, Mar. 29, 2018, page 1. 

changes were made in ECCN 1C991.c.1, 

.c.2, .d.1, and .d.3. 

Neosaxitoxin is a potent neurotoxin 

causing similar symptoms to saxitoxin 

and gonyautoxins, both of which were 

controlled at the 2022 Plenary Meeting, 

in humans and animals. The AG found 

that the high toxicity of neosaxitoxin 

has been demonstrated in scientific 

models, as well as its resistance to heat; 

these factors make this toxin a potential 

threat as it could be used as a biological 

weapon like saxitoxin. Therefore, the 

AG agreed to control neosaxitoxin under 

the ‘‘List of Human and Animal 

Pathogens and Toxins for Export 

Control.’’ BIS details the toxins on this 

list under ECCN 1C351.d. To facilitate 

this addition, item paragraph .d.12 was 

redesignated to control neosaxitoxin 

(NEO), which shifted what had been in 

item paragraphs .d.12 through .d.21 up 

by a factor of one. Given this new 

control, license requirement note 2 to 

ECCN 1C351, which discussed 

neosaxitoxin, is removed, shifting notes 

3 through 5 down by a factor of one. 

Additionally, multiple references to the 

item paragraphs for ricin and saxitoxin 

(now item paragraphs .d.15 and .d.16, 

respectively), had to be updated; these 

conforming changes occurred in: 

§ 742.2(a)(1)(i), (a)(2)(ii), and 

(a)(2)(vi)(B); § 742.18(a)(1), (b)(1)(i), 

(b)(1)(ii), and (b)(1)(iii); ECCNs 1C351, 

1C353, 1C991, 1E001, and 1E351. 

2024 Intersessional 

Prior to the publication of this rule, 

centrifugal separators were already 

controlled under ECCN 2B352.c. Since 

these controls were put into place, the 

technology and characteristics of newly 

available single-use centrifugal 

separators shows a potential for abuse 

comparable to that of the listed 

centrifugal separators. Single-use 

centrifugal separators are new to market 

and are increasingly used in the 

biopharmaceutical industry. Single-use 

centrifugal separators are mainly 

designed for the separation of protein 

expressing cell cultures. Available 

single-use centrifugal separators create 

new ways of processing cell culturebased fermentations with a yield of 98% 

or more. Most single-use centrifugal 

separators systems are flexible in usage 

and simple for scaling. Therefore, the 

AG felt it necessary to revise the control 

text for these items, accounting for 

single-use centrifugal separators. 

To best facilitate these revisions, 

structural changes were made to the 

existing ECCN 2B352.c. Prior to this 

rule, item paragraph .c comprised of c.1 

through c.4, controlling multiple-use 

centrifugal separators. These parameters 

are now combined into a single .c.1, 

with new item paragraphs .c.1.a through 

.c; one parameter, what was .c.2 (a flow 

rate greater than 100 liters per hour), has 

been shifted up into the introductory 

text of .c, such that it applies to both 

single-use and multiple-use centrifugal 

separators. Now, item paragraph .c.2 

will detail control text for single-use 

centrifugal separators, in which all 

components that come in direct contact 

with the substances being processed are 

disposable or single-use. As a 

conforming change, the technical note 

to item paragraph .c is revised to 

include single-use centrifugal 

separators. 

2024 Plenary 

At the 2024 Plenary Meeting, the AG 

reached consensus on controlling 

instruments for automated peptide 

synthesizers. Recent advances in 

peptide synthesis technology and 

instrumentation have increased both the 

speed of peptide synthesis and the 

length of peptide products, including 

peptides and proteins greater than 100 

amino acids in length.1 Most protein 

toxins that are controlled under ECCN 

1C351 are over 100 amino acids in 

length and have an average length of 

300 amino acids (with the notable 

exception of conotoxins, which range 

between 10–100 amino acids in length). 

Consequently, absent the imposition of 

additional controls on the export, 

reexport or transfer (in-country) of 

certain peptide synthesis technology 

and instrumentation (e.g., automated 

peptide synthesizers), there would be an 

increased risk that such technology and 

instrumentation could be used to 

produce controlled toxins for biological 

weapons purposes. 

Automated peptide synthesizers are 

controlled under new item paragraph .k 

in ECCN 2B352. Item paragraph .k, 

contains two subparagraphs, .k.1 and 

.k.2. Item paragraph .k controls peptide 

synthesizers that are both: partly or 

entirely automated (.k.1) and capable of 

generating peptides at a ‘system 

synthesis scale’ of 1 mmol or greater 

(.k.2). Item paragraph .k includes a 

technical note, providing a definition of 

a ‘system synthesis scale’ as follows: 

denotes the maximum amount of 

peptide (mmol) that can be produced by 

the instrument using the largest 

compatible reaction vessels (L). For 

multiple peptides produced in parallel, 

this is the sum of the largest compatible 

reaction vessels (L). The new controls 

also include a nota bene referring 

readers to ECCN 2B350 for other 

chemical reaction vessels or reactors. 

RIN History 

On April 20, 2023, BIS published 

Section 1758 Technology Export 

Controls on Instruments for the 

Automated Chemical Synthesis of 

Peptides (88 FR 24341) (Peptide 

Synthesizers Proposed Rule), seeking 

comments on proposed additional 

controls of peptide synthesizers. That 

rule, published under RIN 0694–AI84, 

which is its U.S. Government regulatory 

identification number, proposed 

identifying automated peptide 

synthesizers as emerging and 

foundational technologies consistent 

with Section 1758 of the Export Control 

Reform Act of 2018 (ECRA), 50 U.S.C. 

4801–4852. Section 1758 provides that 

BIS identify emerging and foundational 

technologies that are essential to U.S. 

national security and are not critical 

technologies, as that term is defined in 

the Defense Production Act of 1950, as 

amended. This final rule finalizes those 

proposed changes; however, this rule 

includes additional changes outside of 

the scope of the Peptide Synthesizers 

Proposed Rule and includes items that 

are not Section 1758 technologies. 

Those changes are consistent with the 

authorities described in Section 1753 of 

ECRA (50 U.S.C. 4812) to regulate the 

export, reexport, and transfer (incountry) of items subject to U.S. 

jurisdiction as well as the mandate to 

seek multilateral controls. Pursuant to 

Section 1762(a) of ECRA (50 U.S.C. 

4821(a)), these changes can be imposed 

in a final rule without prior notice and 

comment. To avoid public confusion, 

BIS created a new RIN for this rule, RIN 

0694–AJ83, to encompass the finalized 

version of the proposed Section 1758 

technologies and the additional 

changes. 

Public Comments in Response to 

Peptide Synthesizers Proposed Rule 

BIS published two actions, an 

Advanced Notice of Proposed 

Rulemaking (87 FR 55930 (Sept. 13, 

2022)) and the Peptide Synthesizers 

Proposed Rule to better inform the AG 

process through public comments. BIS 

received five comments from the public 

on the 2022 advanced notice of 

proposed rulemaking, to which BIS 

responded in the Peptide Synthesizers 

Proposed Rule, but received no 

comments on the Peptide Synthesizers 

Proposed Rule itself. 

Export Control Reform Act of 2018 

On August 13, 2018, the President 

signed into law the John S. McCain 

National Defense Authorization Act for 


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Fiscal Year 2019, which included the 

Export Control Reform Act of 2018 

(ECRA), 50 U.S.C. 4801–4852. ECRA 

provides the legal basis for BIS’s 

principal authorities and serves as the 

authority under which BIS issues this 

rule. In particular, and as noted 

elsewhere, Section 1753 of ECRA (50 

U.S.C. 4812) authorizes the regulation of 

exports, reexports, and transfers (incountry) of items subject to U.S. 

jurisdiction as well as the mandate to 

‘‘seek to secure the cooperation of other 

governments and multilateral 

organizations to impose control systems 

that are consistent, to the extent 

possible, with the controls imposed 

under’’ the EAR. Further, ECRA notes 

that the ‘‘national security and foreign 

policy of the United States require that 

the export, reexport, and in-country 

transfer of items . . . be controlled . . . 

[t]o carry out obligations and 

commitments under international 

agreements and arrangements, including 

multilateral export control regimes.’’ 50 

U.S.C. 4811(2)(E). Further, Section 

1754(a)(1) through (16) of ECRA (50 

U.S.C. 4813(a)(1) through (16)) 

authorizes, inter alia: (1) the 

establishment of a list of controlled 

items; (2) the prohibition of 

unauthorized exports, reexports, and 

transfers (in-country); (3) the 

requirement of licenses or other 

authorizations for exports, reexports, 

and transfers (in-country) of controlled 

items; (4) the apprising of the public of 

changes in policy, regulations, and 

procedures; and (5) any other action 

necessary to carry out ECRA that is not 

otherwise prohibited by law. Pursuant 

to Section 1762(a) of ECRA (50 U.S.C. 

4821(a)), these changes can be imposed 

in a final rule without prior notice and 

comment. 

Rulemaking Requirements 

1. This rule has been determined to be 

a significant regulatory action for 

purposes of Executive Order 12866. 

2. Notwithstanding any other 

provision of law, no person is required 

to respond to or be subject to a penalty 

for failure to comply with a collection 

of information, subject to the 

requirements of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.) (PRA), unless that collection of 

information displays a currently valid 

Office of Management and Budget 

(OMB) Control Number. This regulation 

involves collections previously 

approved by OMB under control 

number 0694–0088, Simplified Network 

Application Processing System, which 

includes, among other things, license 

applications and commodity 

classifications, and carries a burden 

estimate of 29.4 minutes for a manual or 

electronic submission for a total burden 

estimate of 35,739 hours. BIS estimates 

an increase of 40 new licenses each 

year, which would be an increase of 25 

burden hours. This minimal burden 

hour increase is within existing 

estimates for this collection. Additional 

information regarding these collections 

of information—including all 

background materials—can be found at 

https://www.reginfo.gov/public/do/ 

PRAMain by using the search function 

to enter either the title of the collection 

or the OMB Control Number. 

3. This rule does not contain policies 

with federalism implications as that 

term is defined in Executive Order 

13132. 

4. As stated in the preamble of this 

final rule, the amendments contained in 

this rule reflect decisions made by the 

AG. Therefore, pursuant to Section 1762 

of ECRA (50 U.S.C. 4821), this action is 

exempt from the Administrative 

Procedure Act (APA) (5 U.S.C. 553) 

requirements for notice of proposed 

rulemaking, opportunity for public 

participation and delay in effective date. 

Because a notice of proposed 

rulemaking and an opportunity for 

public comment are not required to be 

given for this final rule by the APA or 

any other law, the analytical 

requirements of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.), as 

amended by the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA) (5 U.S.C. 601 et seq.), 

are not applicable. However, 

specifically on the changes related to 

the Peptide Synthesizers Proposed Rule, 

the following applies: Consistent with 

the emerging and foundational 

technologies notice and comment 

requirements in Section 1758(a)(2)(C) of 

ECRA (50 U.S.C. 4817(a)(2)(C)), BIS 

published Peptide Synthesizers 

Proposed Rule to provide the public 

with notice and the opportunity to 

comment on its proposal to amend 

ECCN 2B352 as detailed above, the 

synthesis and collection of which BIS 

had identified for evaluation according 

to the criteria in Section 1758 of ECRA 

pertaining to emerging and foundational 

technologies. No public comments were 

made on the proposed rule. 

Consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA) (5 U.S.C. 601 et seq.), 

BIS has prepared the following final 

regulatory flexibility analysis (FRFA) of 

the impact that this final rule will have 

on small businesses. This only applies 

to the portions of the rule that finalize 

changes to Peptide Synthesizers 

Proposed Rule; the other changes in this 

rule are exempt under ECRA from this 

requirement. 

Description of the Reasons Why Action 

Is Being Considered 

The policy reasons for issuing this 

final rule are discussed in the 

background section of the preamble of 

this document and, consequently, are 

not repeated here. 

Statement of the Objectives of, and 

Legal Basis for, the Proposed Rule; 

Identification of All Relevant Federal 

Rules Which May Duplicate, Overlap or 

Conflict With the Final Rule 

The objective of the Section 1758 

portions of this final rule, and all other 

Section 1758 technology proposed rules 

published by BIS, is to control emerging 

and foundational technologies 

identified by BIS and its interagency 

partners as being essential to U.S. 

national security. 

Other than the discussions above 

about the regulatory history of these 

items, no other Federal rules duplicate, 

overlap, or conflict with this final rule. 

Number and Description of Small 

Entities Regulated by the Final Action 

This final rule will apply to all 

persons engaged in the export, reexport 

or transfer (in-country) of the automated 

peptide synthesizers proposed for 

control under ECCN 2B352 and the 

related ‘‘technology’’ subject to the EAR. 

Presently, these instruments and related 

‘‘technology’’ are used in research and 

development activities in the 

biotechnology field (e.g., U.S. 

university, military and industrial 

laboratories). Therefore, BIS anticipates 

that the final controls will result in 

‘deemed’ export license applications 

(for the release of ‘‘technology’’ to 

foreign nationals located within the 

United States) to allow access to this 

‘‘technology’’ by foreign students and 

faculty at U.S. universities, as well as by 

non-U.S. employees of U.S. biochemical 

firms. There will most likely also be 

‘deemed’ reexport license applications 

for the release of this ‘‘technology’’ to 

third-country foreign nationals located 

in foreign countries who are engaged in 

research and development activities 

involving this ‘‘technology.’’ 

BIS does not collect or maintain the 

data necessary to determine how many 

of the affected persons are small entities 

as that term is used by the Small 

Business Administration. However, in 

the Peptide Synthesizers Proposed Rule, 

BIS was able to estimate the number of 

license applications that the agency 

anticipates receiving as a result of this 

proposed rule and is using that estimate 

as a means of assessing the impact on 


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small businesses. Using the North 

American Industry Classification 

System Codes (NAICS) 541714 

(Research and Technology in 

Biotechnology (except 

Nanobiotechnology)), BIS determined 

that the standard small business size in 

this industry is 1,000 employees. Using 

Table 1a of the Census Bureau’s 2019 

Exports by Company Type and 

Employment Size and extrapolating to 

1,000 employees, BIS then estimated 

that approximately 40% of all identified 

companies that export in this industry 

are small businesses. BIS also estimates 

that it will receive 40 license 

applications per year for the items 

described in this proposed rule (see the 

PRA estimates described in Rulemaking 

Requirements #2, above). Based on that 

information, BIS estimates that the 

agency will receive approximately 16 

license applications per year from small 

businesses, or roughly 40% of the 40 

estimated license applications. 

The amendments finalized in this rule 

also trigger a small information 

collection burden under the U.S. Census 

Bureau’s Foreign Trade Regulations 

(FTR) (15 CFR part 30), which contain 

the Electronic Export Information (EEI) 

filing requirements under the 

Automated Export System (AES). This 

FTR-related information collection has 

been approved by OMB under control 

number 0607–0152 (Automated Export 

System (AES) Program) and carries a 

burden hour estimate of 3 minutes per 

electronic submission. This collection, 

together with the aforementioned EARrelated information collections, would 

result in a total estimated cost increase 

to small businesses of just under $94 

(i.e., 3 hours and 7 minutes × $30 per 

hour) per year. Note that, for purposes 

of consistency, the $30 per hour cost 

estimate used for the EAR-related 

information collections described above 

is also applied to this FTR-related 

information collection (which also 

would involve work performed by 

export compliance specialists). 

Based on the analysis provided above, 

this rule will not impose a significant 

economic impact on a substantial 

number of small businesses. 

Description of the Projected Reporting, 

Recordkeeping, and Other Compliance 

Requirements of the Final Rule 

The changes in this rule and the 

corresponding reporting, recordkeeping, 

and other compliance requirements are 

discussed in the background section of 

the preamble of this document and, 

consequently, are not repeated here. To 

the extent that compliance with the 

changes in this rule would impose a 

burden on persons, including small 

businesses, BIS believes the burden will 

be minimal. 

Significant Alternatives and Underlying 

Analysis 

As noted above, BIS does not believe 

that this rule will have a significant 

economic impact on small businesses. 

Nevertheless, consistent with 5 U.S.C. 

603(c), BIS considered significant 

alternatives as outlined in the Peptide 

Synthesizers Proposed Rule. However, 

those options would have had a greater 

impact not only on small businesses, 

but also on research and development 

laboratories (both academic and 

corporate), which are involved in 

advancing these technologies. BIS has 

determined that finalizing focused 

controls on the items detailed above is 

the least disruptive alternative for 

implementing export controls in a 

manner consistent with controlling 

technology that has been determined, 

through the Section 1758 technology 

interagency process authorized under 

ECRA, to be essential to U.S. national 

security. 

BIS is not allowing different 

compliance or reporting requirements 

for small businesses. If a small business 

is subject to a compliance requirement 

for the export, reexport or transfer (incountry) of this equipment and related 

‘‘technology,’’ then it would submit a 

license application using the same 

process as any other company (i.e., 

electronically via SNAP–R). The license 

application process is free of charge to 

all entities, including small businesses. 

In addition, as noted above, the 

resources and other compliance tools 

made available by BIS typically serve to 

lessen the impact of any EAR license 

requirements on small businesses. 

Lastly, consistent with 5 U.S.C. 

603(c), BIS assessed the use of 

performance standards rather than 

design standards and also considered 

whether an exemption for small 

businesses was practical under the 

circumstances (i.e., within the context 

of the changes finalized by this rule). 

This final rule does not contain an 

exemption for small businesses from 

this license requirement because BIS 

and its interagency partners had to 

assess whether these controls are 

essential to U.S. national security. 

Specifically, items controlled could be 

used for nefarious purposes and, as 

such, controlling these items on the CCL 

may be determined to be essential to 

U.S. national security pursuant to the 

interagency process for identifying 

emerging and foundational technologies 

that is described in Section 1758(a) of 

ECRA (50 U.S.C. 4817(a)). An 

exemption for small businesses would 

undermine the effectiveness of these 

controls. 

Conclusion 

The FRFA prepared by BIS requested 

comments on the analyses and 

conclusions contained therein, 

including the overall conclusion that 

the amendments in the Peptide 

Synthesizers Proposed Rule would not 

have a significant economic impact on 

a substantial number of small entities. 

BIS did not receive any comments in 

response to the analyses and 

conclusions contained in the IRFA for 

the Peptide Synthesizers Proposed Rule. 

List of Subjects 

15 CFR Part 742 

Exports and Terrorism. 

15 CFR Part 774 

Exports, Reporting and recordkeeping 

requirements, Terrorism. 

Accordingly, parts 742, and 774 of the 

Export Administration Regulations (15 

CFR parts 730–774) is amended as 

follows: 

PART 742—CONTROL POLICY—CCL 

BASED CONTROLS 

■ 1. The authority citation for part 742 

continues to read as follows: 

Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 

4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 

3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 

et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 

108–11, 117 Stat. 559; E.O. 12058, 43 FR 

20947, 3 CFR, 1978 Comp., p. 179; E.O. 

12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 

608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 

Comp., p. 950; E.O. 13026, 61 FR 58767, 3 

CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 

44025, 3 CFR, 2001 Comp., p. 783; 

Presidential Determination 2003–23, 68 FR 

26459, 3 CFR, 2004 Comp., p. 320; Notice of 

November 1, 2023, 88 FR 75475 (November 

3, 2023). 

■ 2. Amend § 742.2 by revising 

paragraphs (a)(1)(i), (a)(2)(ii), and 

(a)(2)(vi) to read as follows: 

§ 742.2 Proliferation of chemical and 

biological weapons. 

(a) * * * 

(1) * * * 

(i) Toxins identified in ECCNs 

1C351.d.15 and .16; 

* * * * * 

(2) * * * 

(ii) Human pathogens, zoonoses, 

toxins, animal pathogens, genetically 

modified microorganisms and plant 

pathogens identified in ECCNs 1C351 

(except .d.15 and .16), 1C353 (except 

genetic elements of toxins in ECCN 

1C351.d.15 and .16), and 1C354; and 

* * * * * 


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104412 Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Rules and Regulations 

(vi) Technology (ECCNs 1E001 and 

1E351) for: 

(A) Production and/or disposal of 

chemical precursors described in ECCN 

1C350; and 

(B) Production and/or disposal of 

microbiological commodities described 

in paragraph (a)(2)(ii) of this section 

(except toxins and genetic elements of 

those toxins in ECCN 1C351.d.15 and 

.16). * * * 

* * * * * 

■ 3. Amend § 742.18 by revising 

paragraphs (a)(1), (b)(1)(i) introductory 

text, (b)(1)(ii), and (b)(1)(iii) to read as 

follows: 

§ 742.18 Chemical Weapons Convention 

(CWC or Convention). 

* * * * * 

(a) License requirements—(1) 

Schedule 1 chemicals and mixtures 

controlled under ECCN 1C351. A license 

is required for CW reasons to export or 

reexport Schedule 1 chemicals 

controlled under ECCN 1C351.d.15 or 

.d.16 to all destinations including 

Australia, Canada, and the United 

Kingdom. CW applies to 1C351.d.15 for 

ricin in the form of Ricinus Communis 

AgglutininII (RCAII), which is also 

known as ricin D or Ricinus Communis 

LectinIII (RCLIII), and Ricinus 

Communis LectinIV (RCLIV), which is 

also known as ricin E. CW applies to 

1C351.d.16 for saxitoxin identified by 

C.A.S. #35523–89–8. (Note that the 

advance notification procedures and 

annual reporting requirements 

described in § 745.1 of the EAR also 

apply to exports of Schedule 1 

chemicals.) 

(b) * * * 

(1) * * * 

(i) Exports to States Parties to the 

CWC. Applications to export Schedule 1 

Chemicals controlled under ECCN 

1C351.d.15 or .d.16 to States Parties to 

the CWC (destinations listed in 

supplement no. 2 to part 745 of the 

EAR) generally will be denied, unless 

all of the following conditions are met: 

* * * * * 

(ii) Exports to States not party to the 

CWC. Applications to export Schedule 1 

chemicals controlled under ECCN 

1C351.d.15 or .d.16 to States not Party 

to the CWC (destinations not listed in 

supplement no. 2 to part 745 of the 

EAR) generally will be denied, 

consistent with U.S. obligations under 

the CWC to prohibit exports of these 

chemicals to States not Party to the 

CWC. 

(iii) Reexports. Applications to 

reexport Schedule 1 chemicals 

controlled under ECCN 1C351.d.15 or 

.d.16 generally will be denied to all 

destinations (including both States 

Parties to the CWC and States not Party 

to the CWC). 

* * * * * 

PART 774—THE COMMERCE 

CONTROL LIST 

■ 4. The authority citation for part 774 

continues to read as follows: 

Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 

4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 

8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 

U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 

2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 

U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783. 

Supplement No. 1 to part 774—The 

Commerce Control List 

■ 5. Supplement no.1 to part 774 is 

revised as follows: 

■ a. In Category 1 revise ECCNs 1C350, 

1C351, 1C353, 1C991, 1E001, and 

1E351; and 

■ b. Under Category 2 revise ECCNs 

2B351 and 2B352. 

The revisions read as follows: 

Category 1—Materials, Chemicals, 

Microorganisms and Toxins 

C. ‘‘MATERIALS’’ 

* * * * * 

1C350 Chemicals that may be used as 

precursors for toxic chemical agents (see 

List of Items Controlled). 

License Requirements 

Reason for Control: CB, CW, AT 

Control(s) 

Country chart 

(see supp. No. 1 

to part 738) 

CB applies to entire entry CB Column 2. 

CW applies to 1C350.b and .c. The 

Commerce Country Chart is not designed to 

determine licensing requirements for items 

controlled for CW reasons. A license is 

required, for CW reasons, to export or 

reexport Schedule 2 chemicals and mixtures 

identified in 1C350.b to States not Party to 

the CWC (destinations not listed in 

Supplement No. 2 to part 745 of the EAR). 

A license is required, for CW reasons, to 

export Schedule 3 chemicals and mixtures 

identified in 1C350.c to States not Party to 

the CWC, unless an End-Use Certificate 

issued by the government of the importing 

country has been obtained by the exporter 

prior to export. A license is required, for CW 

reasons, to reexport Schedule 3 chemicals 

and mixtures identified in 1C350.c from a 

State not Party to the CWC to any other State 

not Party to the CWC. (See § 742.18 of the 

EAR for license requirements and policies for 

toxic and precursor chemicals controlled for 

CW reasons. See § 745.2 of the EAR for EndUse Certificate requirements that apply to 

exports of Schedule 3 chemicals to countries 

not listed in Supplement No. 2 to part 745 

of the EAR.) 

AT applies to entire entry. The Commerce 

Country Chart is not designed to determine 

licensing requirements for items controlled 

for AT reasons in 1C350. A license is 

required, for AT reasons, to export or 

reexport items controlled by 1C350 to a 

country in Country Group E:1 of Supplement 

No. 1 to part 740 of the EAR. (See part 742 

of the EAR for additional information on the 

AT controls that apply to Iran, North Korea, 

and Syria. See part 746 of the EAR for 

additional information on sanctions that 

apply to Iran, North Korea, and Syria.) 

License Requirement Notes 

1. SAMPLE SHIPMENTS: Subject to the 

following requirements and restrictions, a 

license is not required for sample shipments 

when the cumulative total of these shipments 

does not exceed a 55-gallon container or 200 

kg of a single chemical to any one consignee 

during a calendar year. A consignee that 

receives a sample shipment under this 

exclusion may not resell, transfer, or reexport 

the sample shipment, but may use the 

sample shipment for any other legal purpose 

unrelated to chemical weapons. 

a. Chemicals Not Eligible 

A. [Reserved] 

B. CWC Schedule 2 chemicals (States not 

Party to the CWC). No CWC Schedule 2 

chemical or mixture identified in 1C350.b is 

eligible for sample shipment to States not 

Party to the CWC (destinations not listed in 

Supplement No. 2 to part 745 of the EAR) 

without a license. 

b. Countries Not Eligible: Countries in 

Country Group E:1 of Supplement No. 1 to 

part 740 of the EAR are not eligible to receive 

sample shipments of any chemicals 

controlled by this ECCN without a license. 

c. Sample shipments that require an EndUse Certificate for CW reasons: No CWC 

Schedule 3 chemical or mixture identified in 

1C350.c is eligible for sample shipment to 

States not Party to the CWC (destinations not 

listed in Supplement No. 2 to part 745 of the 

EAR) without a license, unless an End-Use 

Certificate issued by the government of the 

importing country is obtained by the exporter 

prior to export (see § 745.2 of the EAR for 

End-Use Certificate requirements). 

d. Sample shipments that require a license 

for reasons set forth elsewhere in the EAR: 

Sample shipments, as described in this Note 

1, may require a license for reasons set forth 

elsewhere in the EAR. See, in particular, the 

end-use/end-user restrictions in part 744 of 

the EAR, and the restrictions that apply to 

embargoed countries in part 746 of the EAR. 

e. Annual report requirement. The exporter 

is required to submit an annual written 

report for shipments of samples made under 

this Note 1. The report must be on company 

letterhead stationery (titled ‘‘Report of 

Sample Shipments of Chemical Precursors’’ 

at the top of the first page) and identify the 

chemical(s), Chemical Abstract Service 

Registry (C.A.S.) number(s), quantity(ies), the 

ultimate consignee’s name and address, and 

the date of export for all sample shipments 

that were made during the previous calendar 

year. The report must be submitted no later 

than February 28 of the year following the 

calendar year in which the sample shipments 

were made, to: U.S. Department of 


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Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Rules and Regulations 104413 

Commerce, Bureau of Industry and Security, 

14th Street and Pennsylvania Ave. NW, 

Room 2099B, Washington, DC 20230, Attn: 

‘‘Report of Sample Shipments of Chemical 

Precursors.’’ 

2. MIXTURES: 

a. Mixtures that contain precursor 

chemicals identified in ECCN 1C350, in 

concentrations that are below the levels 

indicated in 1C350.b through .d, are 

controlled by ECCN 1C395 or 1C995 and are 

subject to the licensing requirements 

specified in those ECCNs. 

b. A license is not required under this 

ECCN for a mixture, when the controlled 

chemical in the mixture is a normal 

ingredient in consumer goods packaged for 

retail sale for personal use. Such consumer 

goods are designated EAR99. However, a 

license may be required for reasons set forth 

elsewhere in the EAR. 

Note to Mixtures: Calculation of 

concentrations of AG-controlled chemicals: 

a. Exclusion. No chemical may be added 

to the mixture (solution) for the sole purpose 

of circumventing the Export Administration 

Regulations; 

b. Percent Weight Calculation. When 

calculating the percentage, by weight, of 

ingredients in a chemical mixture, include all 

ingredients of the mixture, including those 

that act as solvents. 

3. COMPOUNDS. Compounds created with 

any chemicals identified in this ECCN 1C350 

may be shipped NLR (No License Required), 

without obtaining an End-Use Certificate, 

unless those compounds are also identified 

in this entry or require a license for reasons 

set forth elsewhere in the EAR. 

4. TESTING KITS: Certain medical, 

analytical, diagnostic, and food testing kits 

containing small quantities of chemicals 

identified in this ECCN 1C350, are excluded 

from the scope of this ECCN and are 

controlled under ECCN 1C395 or 1C995. 

(Note that replacement reagents for such kits 

are controlled by this ECCN 1C350 if the 

reagents contain one or more of the precursor 

chemicals identified in 1C350 in 

concentrations equal to or greater than the 

control levels for mixtures indicated in 

1C350.) 

Technical Notes: 

1. For purposes of this entry, a ‘‘mixture’’ 

is defined as a solid, liquid or gaseous 

product made up of two or more ingredients 

that do not react together under normal 

storage conditions. 

2. The scope of this control applicable to 

Hydrogen Fluoride (see 1C350.d.14 in the List 

of Items Controlled) includes its liquid, 

gaseous, and aqueous phases, and hydrates. 

3. Precursor chemicals in ECCN 1C350 are 

listed by name, Chemical Abstract Service 

(CAS) number and CWC Schedule (where 

applicable). Precursor chemicals of the same 

structural formula (e.g., hydrates, 

isotopically-labeled forms or all possible 

stereoisomers) are controlled by ECCN 

1C350, regardless of name or CAS number. 

CAS numbers are shown to assist in 

identifying whether a particular precursor 

chemical or mixture is controlled under 

ECCN 1C350, irrespective of nomenclature. 

However, CAS numbers cannot be used as 

unique identifiers in all situations because 

some forms of the listed precursor chemical 

have different CAS numbers, and mixtures 

containing a precursor chemical listed in 

ECCN 1C350 may also have different CAS 

numbers. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

LVS: N/A 

GBS: N/A 

List of Items Controlled 

Related Controls: See USML Category XIV for 

related chemical agent binary precursors 

and key precursors ‘‘subject to the ITAR’’ 

(see 22 CFR parts 120 through 130). 

Related Definitions: See § 770.2(k) of the EAR 

for synonyms for the chemicals listed in 

this entry. 

Items: 

a. [Reserved] 

b. Australia Group-controlled precursor 

chemicals also identified as Schedule 2 

chemicals under the CWC, as follows, and 

mixtures in which at least one of the 

following chemicals constitutes 30 percent or 

more of the weight of the mixture: 

b.1. (C.A.S. #7784–34–1) Arsenic 

trichloride; 

b.2. (C.A.S. #76–93–7) Benzilic acid; 

b.3. (C.A.S. #78–38–6) Diethyl 

ethylphosphonate; 

b.4. (C.A.S. #683–08–9) Diethyl 

methylphosphonate; 

b.5. (C.A.S. #15715–41–0) Diethyl 

methylphosphonite; 

b.6. (C.A.S. #2404–03–7) Diethyl-N,Ndimethylphosphoroamidate; 

b.7. (C.A.S. #41480–75–5) N,NDiisopropylaminoethanethiol hydrochloride; 

b.8. (C.A.S. #5842–07–9) N,N-Diisopropylbeta-aminoethane thiol; 

b.9. (C.A.S. #96–80–0) N,N-Diisopropylbeta-aminoethanol; 

b.10. (C.A.S. #96–79–7), N,N-Diisopropylbeta-aminoethyl chloride; 

b.11. (C.A.S. #4261–68–1) N,NDiisopropyl-beta-aminoethyl chloride 

hydrochloride; 

b.12. (C.A.S. #6163–75–3) Dimethyl 

ethylphosphonate; 

b.13. (C.A.S. #756–79–6) Dimethyl 

methylphosphonate; 

b.14. (C.A.S. #677–43–0) N,Ndimethylamino-phosphoryl dichloride; 

b.15. (C.A.S. #1498–40–4) Ethyl 

phosphonous dichloride [Ethyl phosphinyl 

dichloride]; 

b.16. (C.A.S. #430–78–4) Ethyl phosphonus 

difluoride [Ethyl phosphinyl difluoride]; 

b.17. (C.A.S. #1066–50–8) Ethyl 

phosphonyl dichloride; 

b.18. (C.A.S. #993–13–5) 

Methylphosphonic acid; 

b.19. (C.A.S. #676–98–2) 

Methylphosphonothioic dichloride. 

b.20. (C.A.S. #464–07–3) Pinacolyl alcohol; 

b.21. (C.A.S. #1619–34–7) 3-Quinuclidinol; 

b.22. (C.A.S. #111–48–8) Thiodiglycol. 

c. Australia Group-controlled precursor 

chemicals also identified as Schedule 3 

chemicals under the CWC, as follows, and 

mixtures in which at least one of the 

following chemicals constitutes 30 percent or 

more of the weight of the mixture: 

c.1. (C.A.S. #762–04–9) Diethyl phosphite; 

c.2. (C.A.S. #868–85–9) Dimethyl 

phosphite (dimethyl hydrogen phosphite); 

c.3. (C.A.S. #139–87–7) 

Ethyldiethanolamine; 

c.4. (C.A.S. #10025–87–3) Phosphorus 

oxychloride; 

c.5. (C.A.S. #10026–13–8) Phosphorus 

pentachloride; 

c.6. (C.A.S. #7719–12–2) Phosphorus 

trichloride; 

c.7. (C.A.S. #10545–99–0) Sulfur 

dichloride; 

c.8. (C.A.S. #10025–67–9) Sulfur 

monochloride; 

c.9. (C.A.S. #7719–09–7) Thionyl chloride; 

c.10. (C.A.S. #102–71–6) Triethanolamine; 

c.11. (C.A.S. #122–52–1) Triethyl 

phosphite; 

c.12. (C.A.S. #121–45–9) Trimethyl 

phosphite. 

d. Other Australia Group-controlled 

precursor chemicals not also identified as 

Schedule 1, 2, or 3 chemicals under the 

CWC, as follows, and mixtures in which at 

least one of the following chemicals 

constitutes 30 percent or more of the weight 

of the mixture: 

d.1. (C.A.S. #1341–49–7) Ammonium 

hydrogen fluoride; 

d.2. (C.A.S. #107–07–3) 2-Chloroethanol; 

d.3. (C.A.S. #109–89–7) Diethylamine; 

d.4. (C.A.S. #100–37–8) N,NDiethylaminoethanol; 

d.5. (C.A.S. #589–57–1) Diethyl 

chlorophosphite; 

d.6. (C.A.S. #298–06–6) O,O-Diethyl 

phosphorodithioate; 

d.7. (C.A.S. #2465–65–8) O,O-Diethyl 

phosphorothioate; 

d.8. (C.A.S. #108–18–9) Di-isopropylamine; 

d.9. (C.A.S. #124–40–3) Dimethylamine; 

d.10. (C.A.S. #506–59–2) Dimethylamine 

hydrochloride; 

d.11. (C.A.S. #142–84–7) Dipropylamine 

d.12. (C.A.S. #762–77–6) Ethyl 

chlorofluorophosphate; 

d.13. (C.A.S. #1498–51–7) Ethyl 

dichlorophosphate; 

d.14. (C.A.S. #460–52–6) Ethyl 

difluorophosphate; 

d.15. (C.A.S. #7664–39–3) Hydrogen 

fluoride; 

d.16. (C.A.S. #3554–74–3) 3-Hydroxyl-1- 

methylpiperidine; 

d.17. (C.A.S. #76–89–1) Methyl benzilate; 

d.18. (C.A.S. #754–01–8) Methyl 

chlorofluorophosphate; 

d.19. (C.A.S. #677–24–7) Methyl 

dichlorophosphate; 

d.20. (C.A.S. #22382–13–4) Methyl 

difluorophosphate; 

d.21. (C.A.S. #14277–06–6) N,N 

Diethylacetamidine; 

d.22. (C.A.S. #53510–30–8) N,NDiethylbutanamidine; 

d.23. (C.A.S. #90324–67–7) N,NDiethylformamidine; 

d.24. (C.A.S. #1342789–47–2) N,N 

Diethylisobutanamidine; 

d.25. (C.A.S. #84764–73–8) N,NDiethylpropanamidine; 

d.26. (C.A.S. #1315467–17–4) N,NDiisopropylbutanamidine; 

d.27. (C.A.S. #857522–08–8) N,NDiisopropylformamidine; 

d.28. (C.A.S. #2909–14–0) N,NDimethylacetamidine; 


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104414 Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Rules and Regulations 

d.29. (C.A.S. #1340437–35–5) N,NDimethylbutanamidine; 

d.30. (C.A.S. #44205–42–7) N,NDimethylformamidine; 

d.31. (C.A.S. #321881–25–8) N,NDimethylisobutanamidine; 

d.32. (C.A.S. #56776–14–8) N,NDimethylpropanamidine; 

d.33. (C.A.S. #1339586–99–0) N,NDipropylacetamidine; 

d.34. C.A.S. #1342422–35–8) N,NDipropylbutanamidine; 

d.35. (C.A.S. #48044–20–8) N,NDipropylformamidine; 

d.36. (C.A.S. #1342700–45–1) N,NDipropylisobutanamidine; 

d.37. (C.A.S. #1341496–89–6) N,NDipropylpropanamidine; 

d.38. (C.A.S. #1314–80–3) Phosphorus 

pentasulfide; 

d.39. (C.A.S. #75–97–8) Pinacolone; 

d.40. (C.A.S. #7789–29–9) Potassium 

bifluoride; 

d.41. (C.A.S. #151–50–8) Potassium 

cyanide; 

d.42. (C.A.S. #7789–23–3) Potassium 

fluoride; 

d.43. (C.A.S. #3731–38–2) 3-Quinuclidone; 

d.44. (C.A.S. #1333–83–1) Sodium 

bifluoride; 

d.45. (C.A.S. #143–33–9) Sodium cyanide; 

d.46. (C.A.S. #7681–49–4) Sodium 

fluoride; 

d.47. (C.A.S. #16893–85–9) Sodium 

hexafluorosilicate; 

d.48. (C.A.S. #1313–82–2) Sodium sulfide; 

d.49. (C.A.S. #637–39–8) Triethanolamine 

hydrochloride; 

d.50. (C.A.S. #116–17–6) Tri-isopropyl 

phosphite. 

1C351 Human and animal pathogens and 

‘‘toxins,’’ as follows (see List of Items 

Controlled). 

License Requirements 

Reason for Control: CB, CW, AT 

Control(s) 

Country chart 

(see Supp. No. 1 

to part 738) 

CB applies to items controlled by 1C351.d.15 

and .16.

CB Column 1. 

CB applies to entire 

entry.

CB Column 2. 

CW applies to 1C351.d.15 and .d.16 and a 

license is required for CW reasons for all 

destinations, including Australia, Canada, 

and the United Kingdom, as follows: CW 

applies to 1C351.d.15 for ricin in the form of 

(1) Ricinus communis AgglutininII (RCAII), 

also known as ricin D or Ricinus Communis 

LectinIII (RCLIII) and (2) Ricinus communis 

LectinIV (RCLIV), also known as ricin E. CW 

applies to 1C351.d.16 for saxitoxin identified 

by C.A.S. #35523–89–8. See § 742.18 of the 

EAR for licensing information pertaining to 

chemicals subject to restriction pursuant to 

the Chemical Weapons Convention (CWC). 

The Commerce Country Chart is not designed 

to determine licensing requirements for items 

controlled for CW reasons. 

Control(s) 

Country chart 

(see Supp. No. 1 

to part 738) 

AT applies to entire entry Column 1. 

License Requirement Notes 

1. All vaccines and ‘immunotoxins’ are 

excluded from the scope of this entry. Certain 

medical products and diagnostic and food 

testing kits that contain biological toxins 

controlled under 1C351.d, with the exception 

of toxins controlled for CW reasons under 

1C351.d.15 or .d.16, are excluded from the 

scope of this entry. Vaccines, 

‘immunotoxins’, certain medical products, 

and diagnostic and food testing kits excluded 

from the scope of this entry are controlled 

under ECCN 1C991. 

2. Clostridium perfringens strains, other 

than the epsilon toxin-producing strains of 

Clostridium perfringens described in 

1C351.c.12, are excluded from the scope of 

this entry, since they may be used as positive 

control cultures for food testing and quality 

control. 

3. Unless specified elsewhere in this ECCN 

1C351 (e.g., in License Requirement Notes 1– 

3), this ECCN controls all biological agents 

and ‘‘toxins,’’ regardless of quantity or 

attenuation, that are identified in the List of 

Items Controlled for this ECCN, including 

small quantities or attenuated strains of 

select biological agents or ‘‘toxins’’ that are 

excluded from the lists of select biological 

agents or ‘‘toxins’’ by the Animal and Plant 

Health Inspection Service (APHIS), U.S. 

Department of Agriculture (USDA), or the 

Centers for Disease Control and Prevention 

(CDC), U.S. Department of Health and 

Human Services (HHS), in accordance with 

their regulations in 9 CFR part 121 and 42 

CFR part 73, respectively. 

4. Biological agents and pathogens are 

controlled under this ECCN 1C351 when they 

are an isolated live culture of a pathogen 

agent, or a preparation of a toxin agent that 

has been isolated or extracted from any 

source or material, including living material 

that has been deliberately inoculated or 

contaminated with the agent. Isolated live 

cultures of a pathogen agent include live 

cultures in dormant form or in dried 

preparations, whether the agent is natural, 

enhanced or modified. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

LVS: N/A 

GBS: N/A 

List of Items Controlled 

Related Controls: (1) Certain forms of ricin 

and saxitoxin in 1C351.d.15 and .d.16 are 

CWC Schedule 1 chemicals (see § 742.18 of 

the EAR). The U.S. Government must 

provide advance notification and annual 

reports to the OPCW of all exports of 

Schedule 1 chemicals. See § 745.1 of the 

EAR for notification procedures. See 22 

CFR part 121, Category XIV for CWC 

Schedule 1 chemicals that are ‘‘subject to 

the ITAR.’’ (2) The Animal and Plant 

Health Inspection Service (APHIS), U.S. 

Department of Agriculture, and the Centers 

for Disease Control and Prevention (CDC), 

U.S. Department of Health and Human 

Services, maintain controls on the 

possession, use, and transfer within the 

United States of certain items controlled by 

this ECCN (for APHIS, see 7 CFR 331.3(b), 

9 CFR 121.3(b), and 9 CFR 121.4(b); for 

CDC, see 42 CFR 73.3(b) and 42 CFR 

73.4(b)). (3) See USML Category XIV for 

modified biological agents and biologically 

derived substances that are ‘‘subject to the 

ITAR’’ (see 22 CFR parts 120 through 130). 

Related Definitions: For the purposes of this 

entry, ‘immunotoxins’ are monoclonal 

antibodies linked to a toxin with the 

intention of destroying a specific target cell 

while leaving adjacent cells intact. 

Items: 

a. Viruses identified on the Australia 

Group (AG) ‘‘List of Human and Animal 

Pathogens and Toxins for Export Control,’’ as 

follows: 

a.1. African horse sickness virus; 

a.2. African swine fever virus; 

a.3. Andes virus; 

a.4. Avian influenza (AI) viruses identified 

as having high pathogenicity (HP), as follows: 

a.4.a. AI viruses that have an intravenous 

pathogenicity index (IVPI) in 6-week-old 

chickens greater than 1.2; or 

a.4.b. AI viruses that cause at least 75% 

mortality in 4- to 8-week-old chickens 

infected intravenously. 

Note: 

Avian influenza (AI) viruses of the H5 or 

H7 subtype that do not have either of the 

characteristics described in 1C351.a.4 

(specifically, 1C351.a.4.a or .a.4.b) should be 

sequenced to determine whether multiple 

basic amino acids are present at the cleavage 

site of the haemagglutinin molecule (HA0). If 

the amino acid motif is similar to that 

observed for other HPAI isolates, then the 

isolate being tested should be considered as 

HPAI and the virus is controlled under 

1C351.a.4. 

a.5. Bluetongue virus; 

a.6. Chapare virus; 

a.7. Chikungunya virus; 

a.8. Choclo virus; 

a.9. Classical swine fever virus (Hog 

cholera virus); 

a.10. Crimean-Congo hemorrhagic fever 

virus; 

a.11. Dobrava-Belgrade virus; 

a.12. Eastern equine encephalitis virus; 

a.13. Ebolavirus (includes all members of 

the Ebolavirus genus); 

a.14. Foot-and-mouth disease virus; 

a.15. Goatpox virus; 

a.16. Guanarito virus; 

a.17. Hantaan virus; 

a.18. Hendra virus (Equine morbillivirus); 

a.19. Japanese encephalitis virus; 

a.20. Junin virus; 

a.21. Kyasanur Forest disease virus; 

a.22. Laguna Negra virus; 

a.23. Lassa virus; 

a.24. Louping ill virus; 

a.25. Lujo virus; 

a.26. Lumpy skin disease virus; 

a.27. Lymphocytic choriomeningitis virus; 

a.28. Machupo virus; 

a.29. Marburgvirus (includes all members 

of the Marburgvirus genus); 

a.30. Middle East respiratory syndromerelated coronavirus (MERS-related 

coronavirus); 

a.31. Monkeypox virus; 

a.32. Murray Valley encephalitis virus; 

a.33. Newcastle disease virus; 

a.34. Nipah virus; 

a.35. Omsk hemorrhagic fever virus; 


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a.36. Oropouche virus; 

a.37. Peste-des-petits ruminants virus; 

a.38. Porcine Teschovirus; 

a.39. Powassan virus; 

a.40. Rabies virus and all other members of 

the Lyssavirus genus; 

a.41. Reconstructed 1918 influenza virus; 

Technical Note: 

1C351.a.41 includes reconstructed 

replication competent forms of the 1918 

pandemic influenza virus containing any 

portion of the coding regions of all eight gene 

segments. 

a.42. Rift Valley fever virus; 

a.43. Rinderpest virus; 

a.44. Rocio virus; 

a.45. Sabia virus; 

a.46. Seoul virus; 

a.47. Severe acute respiratory syndromerelated coronavirus (SARS-related 

coronavirus); 

a.48. Sheeppox virus; 

a.49. Sin Nombre virus; 

a.50. St. Louis encephalitis virus; 

a.51. Suid herpesvirus 1 (Pseudorabies 

virus; Aujeszky’s disease); 

a.52. Swine vesicular disease virus; 

a.53. Tick-borne encephalitis virus (Far 

Eastern subtype, formerly known as Russian 

Spring-Summer encephalitis virus—see 

1C351.b.3 for Siberian subtype); 

a.54. Variola virus; 

a.55. Venezuelan equine encephalitis virus; 

a.56. Vesicular stomatitis virus; 

a.57. Western equine encephalitis virus; or 

a.58. Yellow fever virus. 

b. Viruses identified on the APHIS/CDC 

‘‘select agents’’ lists (see Related Controls 

paragraph #2 for this ECCN), but not 

identified on the Australia Group (AG) ‘‘List 

of Human and Animal Pathogens and Toxins 

for Export Control,’’ as follows: 

b.1. [Reserved]; 

b.2. [Reserved]; or 

b.3. Tick-borne encephalitis virus (Siberian 

subtype, formerly West Siberian virus—see 

1C351.a.53 for Far Eastern subtype). 

c. Bacteria identified on the Australia 

Group (AG) ‘‘List of Human and Animal 

Pathogens and Toxins for Export Control,’’ as 

follows: 

c.1. Bacillus anthracis; 

c.2. Brucella abortus; 

c.3. Brucella melitensis; 

c.4. Brucella suis; 

c.5. Burkholderia mallei (Pseudomonas 

mallei); 

c.6. Burkholderia pseudomallei 

(Pseudomonas pseudomallei); 

c.7. Chlamydia psittaci (Chlamydophila 

psittaci); 

c.8. Clostriduim argentinense (formerly 

known as Clostridium botulinum Type G), 

botulinum neurotoxin producing strains; 

c.9. Clostridium baratii, botulinum 

neurotoxin producing strains; 

c.10. Clostridium botulinum; 

c.11. Clostridium butyricum, botulinum 

neurotoxin producing strains; 

c.12. Clostridium perfringens, epsilon 

toxin producing types; 

c.13. Coxiella burnetii; 

c.14. Francisella tularensis; 

c.15. Mycoplasma capricolum subspecies 

capripneumoniae (‘‘strain F38’’); 

c.16. Mycoplasma mycoides subspecies 

mycoides SC (small colony) (a.k.a. contagious 

bovine pleuropneumonia); 

c.17. Rickettsia prowazekii; 

c.18. Salmonella enterica subspecies 

enterica serovar Typhi (Salmonella typhi); 

c.19. Shiga toxin producing Escherichia 

coli (STEC) of serogroups O26, O45, O103, 

O104, O111, O121, O145, O157, and other 

shiga toxin producing serogroups; 

Note: 

Shiga toxin producing Escherichia coli 

(STEC) includes, inter alia, 

enterohaemorrhagic E. coli (EHEC), verotoxin 

producing E. coli (VTEC) or verocytotoxin 

producing E. coli (VTEC). 

c.20. Shigella dysenteriae; 

c.21. Vibrio cholerae; or 

c.22. Yersinia pestis. 

d. ‘‘Toxins’’ identified on the Australia 

Group (AG) ‘‘List of Human and Animal 

Pathogens and Toxins for Export Control,’’ as 

follows, or their subunits: 

d.1. Abrin; 

d.2. Aflatoxins; 

d.3. Botulinum neurotoxins; 

d.4. Brevetoxins; 

d.5. Clostridium perfringens alpha, beta 1, 

beta 2, epsilon and iota toxins; 

d.6. Conotoxins; 

d.7. Diacetoxyscirpenol; 

d.8. Gonyautoxins; 

d.9. HT–2 toxin; 

d.10. Microcystins (Cyanginosins); 

d.11. Modeccin; 

d.12. Neosaxitoxin (NEO); 

d.13. Nodularins; 

d.14. Palytoxin; 

d.15. Ricin; 

d.16. Saxitoxin; 

d.17. Shiga toxins (shiga-like toxins, 

verotoxins, and verocytotoxins); 

d.18. Staphylococcus aureus enterotoxins, 

hemolysin alpha toxin, and toxic shock 

syndrome toxin (formerly known as 

Staphylococcus enterotoxin F); 

d.19. T–2 toxin; 

d.20. Tetrodotoxin; 

d.21. Viscumin (Viscum album lectin 1); or 

d.22. Volkensin. 

e. ‘‘Fungi’’, as follows: 

e.1. Coccidioides immitis; or 

e.2. Coccidioides posadasii. 

* * * * * 

1C353 Genetic elements and genetically 

modified organisms, as follows (see List 

of Items Controlled). 

License Requirements 

Reason for Control: CB, AT 

Control(s) 

Country chart 

(see Supp. No. 1 

to part 738) 

CB applies to genetic 

elements of items controlled by 1C351.d.15 

and .16.

CB Column 1. 

CB applies to entire 

entry.

CB Column 2. 

AT applies to entire entry AT Column 1. 

License Requirements Notes: 

1. Vaccines that contain genetic elements 

or genetically modified organisms identified 

in this ECCN are controlled by ECCN 1C991. 

2. Unless specified elsewhere in this ECCN 

1C353 (e.g., in License Requirement Note 1), 

this ECCN controls genetic elements or 

genetically modified organisms for all 

biological agents and ‘‘toxins,’’ regardless of 

quantity or attenuation, that are identified in 

the List of Items Controlled for this ECCN, 

including genetic elements or genetically 

modified organisms for attenuated strains of 

select biological agents or ‘‘toxins’’ that are 

excluded from the lists of select biological 

agents or ‘‘toxins’’ by the Animal and Plant 

Health Inspection Service (APHIS), U.S. 

Department of Agriculture, or the Centers for 

Disease Control and Prevention (CDC), U.S. 

Department of Health and Human Services, 

in accordance with the APHIS regulations in 

7 CFR part 331 and 9 CFR part 121 and the 

CDC regulations in 42 CFR part 73. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

LVS: N/A 

GBS: N/A 

List of Items Controlled 

Related Controls: (1) The Animal and Plant 

Health Inspection Service (APHIS), U.S. 

Department of Agriculture, and the Centers 

for Disease Control and Prevention (CDC), 

U.S. Department of Health and Human 

Services, maintain controls on the 

possession, use, and transfer within the 

United States of certain items controlled by 

this ECCN, including (but not limited to) 

certain genetic elements, recombinant 

nucleic acids, and recombinant organisms 

associated with the agents or toxins in 

ECCN 1C351 or 1C354 (for APHIS, see 7 

CFR 331.3(c), 9 CFR 121.3(c), and 9 CFR 

121.4(c); for CDC, see 42 CFR 73.3(c) and 

42 CFR 73.4(c)). (2) See USML Category 

XIV for modified biological agents and 

biologically derived substances that are 

‘‘subject to the ITAR’’ (see 22 CFR parts 

120 through 130). 

Related Definition: N/A 

Items: 

a. Any genetically modified organism that 

contains, or any genetic element that codes 

for, any of the following: 

a.1. Any gene, genes, translated product or 

translated products specific to any virus 

controlled by 1C351.a or .b or 1C354.c; 

a.2. Any gene or genes specific to any 

bacterium controlled by 1C351.c or 1C354.a, 

or any fungus controlled by 1C351.e or 

1C354.b, and which; 

a.2.a. In itself or through its transcribed or 

translated products represents a significant 

hazard to human, animal or plant health; or 

a.2.b. Could endow or enhance 

pathogenicity; or 

a.3. Any toxins, or their subunits, 

controlled by 1C351.d. 

b. [Reserved]. 

Technical Notes: 

1. Genetically modified organisms include 

organisms in which the nucleic acid 

sequences have been created or altered by 

deliberate molecular manipulation. 

2. ‘‘Genetic elements’’ include, inter alia, 

chromosomes, genomes, plasmids, 

transposons, vectors, and inactivated 

organisms containing recoverable nucleic 

acid fragments, whether genetically modified 

or unmodified, or chemically synthesized in 

whole or in part. For the purposes of this 


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ECCN 1C353, nucleic acids from an 

inactivated organism, virus, or sample are 

considered to be ‘recoverable’ if the 

inactivation and preparation of the material 

is intended or known to facilitate isolation, 

purification, amplification, detection, or 

identification of nucleic acids. 

3. This ECCN does not control nucleic acid 

sequences of shiga toxin producing 

Escherichia coli of serogroups O26, O45, 

O103, O104, O111, O121, O145, O157, and 

other shiga toxin producing serogroups, other 

than those genetic elements coding for shiga 

toxin, or for its subunits. 

4. ‘Endow or enhance pathogenicity’ is 

defined as when the insertion or integration 

of the nucleic acid sequence or sequences is/ 

are likely to enable or increase a recipient 

organism’s ability to be used to deliberately 

cause disease or death. This might include 

alterations to, inter alia: virulence, 

transmissibility, stability, route of infection, 

host range, reproducibility, ability to evade or 

suppress host immunity, resistance to 

medical countermeasures, or detectability. 

* * * * * 

1C991 Vaccines, immunotoxins, medical 

products, diagnostic and food testing 

kits, as follows (see List of Items 

Controlled). 

License Requirements 

Reason for Control: CB, AT 

Control(s) 

Country chart 

(See Supp. No. 1 

to part 738) 

CB applies to 1C991.c ... CB Column 3. 

AT applies to entire entry AT Column 1. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

LVS: N/A 

GBS: N/A 

List of Items Controlled 

Related Controls: (1) Medical products 

containing ricin or saxitoxin, as follows, 

are controlled for CW reasons under ECCN 

1C351: 

(a) Ricinus communis AgglutininII (RCAII), 

also known as ricin D, or Ricinus 

Communis LectinIII (RCLIII); 

(b) Ricinus communis LectinIV (RCLIV), also 

known as ricin E; or 

(c) Saxitoxin identified by C.A.S. #35523–89– 

8. 

(2) The export of a ‘‘medical product’’ that is 

an ‘‘Investigational New Drug’’ (IND), as 

defined in 21 CFR 312.3, is subject to 

certain U.S. Food and Drug Administration 

(FDA) requirements that are independent 

of the export requirements specified in this 

ECCN or elsewhere in the EAR. These FDA 

requirements are described in 21 CFR 

312.110 and must be satisfied in addition 

to any requirements specified in the EAR. 

(3) Also see 21 CFR 314.410 for FDA 

requirements concerning exports of new 

drugs and new drug substances. 

Related Definitions: For the purpose of this 

entry, ‘immunotoxins’ are monoclonal 

antibodies linked to a toxin with the 

intention of destroying a specific target cell 

while leaving adjacent cells intact. For the 

purpose of this entry, ‘medical products’ 

are: (1) Pharmaceutical formulations 

designed for testing and human (or 

veterinary) administration in the treatment 

of medical conditions; (2) prepackaged for 

distribution as clinical or medical 

products; and (3) approved by the U.S. 

Food and Drug Administration either to be 

marketed as clinical or medical products or 

for use as an ‘‘Investigational New Drug’’ 

(IND) (see 21 CFR part 312). For the 

purpose of this entry, ‘diagnostic and food 

testing kits’ are specifically developed, 

packaged and marketed for diagnostic or 

public health purposes. Biological toxins 

in any other configuration, including bulk 

shipments, or for any other end-uses are 

controlled by ECCN 1C351. For the 

purpose of this entry, ‘vaccine’ is defined 

as a medicinal (or veterinary) product in a 

pharmaceutical formulation, approved by 

the U.S. Food and Drug Administration or 

the U.S. Department of Agriculture to be 

marketed as a medical (or veterinary) 

product or for use in clinical trials, that is 

intended to stimulate a protective 

immunological response in humans or 

animals in order to prevent disease in 

those to whom or to which it is 

administered. 

Items: 

Technical Note: For purposes of the 

controls described in this ECCN, ‘toxins’ 

refers to those toxins, or their subunits, 

controlled under ECCN 1C351.d. 

a. Vaccines containing, or designed for use 

against, items controlled by ECCN 1C351, 

1C353 or 1C354. 

b. Immunotoxins containing toxins 

controlled by 1C351.d; 

c. Medical products that contain any of the 

following: 

c.1. Toxins controlled by ECCN 1C351.d 

(except for botulinum neurotoxins controlled 

by ECCN 1C351.d.3, conotoxins controlled by 

ECCN 1C351.d.6, or items controlled for CW 

reasons under ECCN 1C351.d.15 or .d.16); or 

c.2. Genetically modified organisms or 

genetic elements controlled by ECCN 

1C353.a.3 (except for those that contain, or 

code for, botulinum neurotoxins controlled 

by ECCN 1C351.d.3 or conotoxins controlled 

by ECCN 1C351.d.6); 

d. Medical products not controlled by 

1C991.c that contain any of the following: 

d.1. Botulinum neurotoxins controlled by 

ECCN 1C351.d.3; 

d.2. Conotoxins controlled by ECCN 

1C351.d.6; or 

d.3. Genetically modified organisms or 

genetic elements controlled by ECCN 

1C353.a.3 that contain, or code for, 

botulinum neurotoxins controlled by ECCN 

1C351.d.3 or conotoxins controlled by ECCN 

1C351.d.6; 

e. Diagnostic and food testing kits 

containing toxins controlled by ECCN 

1C351.d (except for items controlled for CW 

reasons under ECCN 1C351.d.15 or .d.16). 

* * * * * 

E. ‘‘Technology’’ 

1E001 ‘‘Technology’’ according to the 

General Technology Note for the 

‘‘development’’ or ‘‘production’’ of items 

controlled by 1A002, 1A003, 1A004, 

1A005, 1A006.b, 1A007, 1A008 1A101, 

1A231, 1B (except 1B608, 1B613 or 

1B999), or 1C (except 1C355, 1C608, 

1C980 to 1C984, 1C988, 1C990, 1C991, 

1C995 to 1C999). 

License Requirements 

Reason for Control: NS, MT, NP, CB, RS, AT 

Control(s) 

Country chart 

(see Supp. No. 1 

to part 738) 

NS applies to ‘‘technology’’ for items controlled by 1A002, 

1A003, 1A005, 

1A006.b, 1A007, 

1B001 to 1B003, 

1B018, 1C001 to 

1C011, or 1C018.

NS Column 1. 

NS applies to ‘‘technology’’ for items controlled by 1A004.NS Column 2. 

MT applies to ‘‘technology’’ for items controlled by 1A101, 

1B001, 1B101, 1B102, 

1B115 to 1B119, 

1C001, 1C007, 1C011, 

1C101, 1C102, 1C107, 

1C111, 1C116, 1C117, 

or 1C118 for MT reasons.

MT Column 1. 

NP applies to ‘‘technology’’ for items controlled by 1A002, 

1A007, 1A231, 1B001, 

1B101, 1B201, 1B225, 

1B226, 1B228 to 

1B234, 1C002, 1C010, 

1C111, 1C116, 1C202, 

1C210, 1C216, 1C225 

to 1C237, or 1C239 to 

1C241 for NP reasons.

NP Column 1. 

CB applies to ‘‘technology’’ for items controlled by 1C351.d.15 

and .16 and the 1C353 

genetic elements of 

toxins in ECCN 

1C351.d.15 and .16.

CB Column 1. 

CB applies to ‘‘technology’’ for items controlled by 1C351, 

1C353, or 1C354; and 

CB applies to ‘‘technology’’ for materials 

controlled by 1C350 

and for chemical detection systems and 

dedicated detectors 

therefor, in 1A004.c, 

that also have the 

technical characteristics described in 

2B351.a.

CB Column 2. 

RS applies to technology 

for equipment controlled in 1A004.d.

RS Column 2. 

AT applies to entire entry AT Column 1. 

Reporting Requirements 

See § 743.1 of the EAR for reporting 

requirements for exports under License 

Exceptions, and Validated End-User 

authorizations. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

TSR: Yes, except for the following: 

(1) Items controlled for MT reasons; or 

(2) Exports and reexports to destinations 

outside of those countries listed in Country 

Group A:5 (See Supplement No. 1 to part 


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740 of the EAR) of ‘‘technology’’ for the 

‘‘development’’ or production’’ of the 

following: 

(a) Items controlled by 1C001; or 

(b) Items controlled by 1A002.a which are 

composite structures or laminates having 

an organic ‘‘matrix’’ and being made from 

materials listed under 1C010.c or 1C010.d. 

Special Conditions for STA 

STA: License Exception STA may not be 

used to ship or transmit ‘‘technology’’ 

according to the General Technology Note 

for the ‘‘development’’ or ‘‘production’’ of 

equipment and materials specified by 

ECCNs 1A002, 1C001, 1C007.c, 1C010.c or 

d or 1C012 to any of the destinations listed 

in Country Group A:6 (See Supplement No. 

1 to part 740 of the EAR). 

List of Items Controlled 

Related Controls (1) Also see ECCNs 1E101, 

1E201, and 1E202. (2) See ECCN 1E608 for 

‘‘technology’’ for items classified under 

ECCN 1B608 or 1C608 that, immediately 

prior to July 1, 2014, were classified under 

ECCN 1B018.a or 1C018.b through .m (note 

that ECCN 1E001 controls ‘‘development’’ 

and ‘‘production’’ ‘‘technology’’ for 

chlorine trifluoride controlled by ECCN 

1C111.a.3.f—see ECCN 1E101 for controls 

on ‘‘use’’ ‘‘technology’’ for chlorine 

trifluoride). (3) See ECCN 1E002.g for 

control libraries (parametric technical 

databases) ‘‘specially designed’’ or 

modified to enable equipment to perform 

the functions of equipment controlled 

under ECCN 1A004.c (Nuclear, biological 

and chemical (NBC) detection systems) or 

ECCN 1A004.d (Equipment for detecting or 

identifying explosives residues). (4) 

‘‘Technology’’ for lithium isotope 

separation (see related ECCN 1B233) and 

‘‘technology’’ for items described in ECCN 

1C012 are subject to the export licensing 

authority of the Department of Energy (see 

10 CFR part 810). (5) ‘‘Technology’’ for 

items described in ECCN 1A102 is ‘‘subject 

to the ITAR’’ (see 22 CFR parts 120 through 

130). 

Related Definitions: N/A 

Items: 

The list of items controlled is contained in 

the ECCN heading. 

* * * * * 

1E351 ‘‘Technology’’ according to the 

‘‘General Technology Note’’ for the 

disposal of chemicals or microbiological 

materials controlled by 1C350, 1C351, 

1C353, or 1C354. 

License Requirements 

Reason for Control: CB, AT 

Control(s) 

Country chart 

(see Supp. No. 1 

to part 738) 

CB applies to ‘‘technology’’ for the disposal of items controlled by 1C351.d.15 

and .16 and the 1C353 

genetic elements of 

toxins in ECCN 

1C351.d.15 and .16.

CB Column 1. 

Control(s) 

Country chart 

(see Supp. No. 1 

to part 738) 

CB applies to ‘‘technology’’ for the disposal of items controlled by 1C351, 

1C353, or 1C354; and 

CB applies to ‘‘technology’’ for the disposal of items controlled by 1C350.

CB Column 2. 

AT applies to entire entry AT Column 1. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

TSR: N/A 

List of Items Controlled 

Related Controls: N/A 

Related Definitions: N/A 

Items: 

The list of items controlled is contained in 

the ECCN heading. 

* * * * * 

Category 2—Materials Processing 

B. ‘‘Test’’, ‘‘Inspection’’ and ‘‘Production 

Equipment’’ 

* * * * * 

2B351 Toxic gas monitors and monitoring 

systems, and their dedicated detecting 

‘‘parts’’ and ‘‘components’’ (i.e., 

detectors, sensor devices, and 

replaceable sensor cartridges), as 

follows, except those systems and 

detectors controlled by ECCN 1A004.c 

(see List of Items Controlled). 

License Requirements 

Reason for Control: CB, AT 

Control(s) 

Country chart 

(see Supp. No. 1 to 

part 738) 

CB applies to entire 

entry.

CB Column 2. 

AT applies to entire entry AT Column 1. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

LVS: N/A 

GBS: N/A 

List of Items Controlled 

Related Controls: See ECCN 2D351 for 

‘‘software’’ for toxic gas monitors and 

monitoring systems, and their dedicated 

detecting ‘‘parts’’ and ‘‘components,’’ 

controlled by this ECCN. Also see ECCN 

1A004, which controls chemical detection 

systems and ‘‘specially designed’’ ‘‘parts’’ 

and ‘‘components’’ therefor that are 

‘‘specially designed’’ or modified for 

detection or identification of chemical 

warfare agents, but not ‘‘specially 

designed’’ for military use, and ECCN 

1A995, which controls certain detection 

equipment, ‘‘parts’’ and ‘‘components’’ not 

controlled by ECCN 1A004 or by this 

ECCN. 

Related Definitions: (1) For the purposes of 

this entry, the term ‘‘dedicated’’ means 

committed entirely to a single purpose or 

device. (2) For the purposes of this entry, 

the term ‘‘continuous operation’’ describes 

the capability of the equipment to operate 

on line without human intervention. The 

intent of this entry is to control toxic gas 

monitors and monitoring systems capable 

of collection and detection of samples in 

environments such as chemical plants, 

rather than those used for batch-mode 

operation in laboratories. 

Items: 

a. Designed for continuous operation and 

usable for the detection of chemical warfare 

agents or precursor chemicals controlled by 

1C350 ‘minimum detection limit’ of 0.3 mg/ 

m3; or 

b. Designed for the detection of 

cholinesterase-inhibiting activity. 

Technical note: The ‘minimum detection 

limit‘ of toxic gas monitors or monitoring 

systems is the lowest detectable 

concentration of the analyte required to 

produce a signal greater than three times the 

standard deviation of the toxic gas monitor’s 

or monitoring system’s signal when 

measuring a blank sample. 

In the case of toxic gas monitors or 

monitoring systems having a deadband or 

programmed zero suppression, the ‘minimum 

detection limit’ is the lowest detectable 

concentration required to produce a reading. 

2B352 Equipment Capable of Use in 

Handling Biological Materials, as 

Follows (See List of Items Controlled). 

License Requirements 

Reason for Control: CB, AT 

Control(s) 

Country chart 

(see Supp. No. 1 to 

part 738) 

CB applies to entire 

entry.

CB Column 2. 

AT applies to entire entry AT Column 1. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

LVS: N/A 

GBS: N/A 

List of Items Controlled 

Related Controls: See ECCNs 1A004 and 

1A995 for protective equipment that is not 

covered by this entry. Also see ECCN 

9A120 for controls on certain ‘‘UAV’’ 

systems designed or modified to dispense 

an aerosol and capable of carrying 

elements of a payload in the form of a 

particulate or liquid, other than fuel 

‘‘parts’’ or ‘‘components’’ of such vehicles, 

of a volume greater than 20 liters. 

Related Definitions: (1) ‘‘Lighter than air 

vehicles’’—balloons and airships that rely 

on hot air or on lighter-than-air gases, such 

as helium or hydrogen, for their lift. (2) 

‘‘UAVs’’—Unmanned Aerial Vehicles. (3) 

‘‘VMD’’—Volume Median Diameter. 

Items: 

a. Containment facilities and related 

equipment, as follows: 

a.1. Complete containment facilities at P3 

or P4 containment level. 

Technical Note to 2B352.a.1: P3 or P4 

(BL3, BL4, L3, L4) containment levels are as 

specified in the WHO Laboratory Biosafety 

Manual (3rd edition, Geneva, 2004). 

a.2. Equipment designed for fixed 

installation in containment facilities 

specified in paragraph a.1 of this ECCN, as 

follows: 


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a.2.a. Double-door pass-through 

decontamination autoclaves; 

a.2.b. Breathing air suit decontamination 

showers; 

a.2.c. Mechanical-seal or inflatable-seal 

walkthrough doors. 

b. Fermenters and components as follows: 

b.1. Fermenters capable of cultivation of 

micro-organisms or of live cells for the 

production of viruses or toxins, without the 

propagation of aerosols, having a total 

internal volume of 20 liters or greater. 

b.2. Components designed for such 

fermenters, as follows: 

b.2.a. Cultivation chambers designed to be 

sterilized or disinfected in situ; 

b.2.b. Cultivation chamber holding devices; 

or 

b.2.c. Process control units capable of 

simultaneously monitoring and controlling 

two or more fermentation system parameters 

(e.g., temperature, pH, nutrients, agitation, 

dissolved oxygen, air flow, foam control). 

Technical Notes to 2B352.b: 

1. Fermenters include bioreactors 

(including single-use (disposable) 

bioreactors), chemostats and continuous-flow 

systems. 

2. Cultivation chamber holding devices 

controlled by 2B352.b.2.b include single-use 

cultivation chambers with rigid walls. 

c. Centrifugal separators capable of 

continuous separation, without the 

propagation of aerosols, having a flow rate 

greater than 100 liters per hour, as follows: 

c.1. Centrifugal separators having all of the 

following characteristics: 

c.1.a. One or more sealing joints within the 

steam containment area; 

c.1.b. Components of polished stainless 

steel or titanium; and 

c.1.c. Capable of in-situ steam sterilization 

in a closed state. 

c.2. Single-use centrifugal separators, in 

which all components that come in direct 

contact with the substances being processed 

are disposable or single-use. 

Technical Note to 2B352.c: Centrifugal 

separators and single-use centrifugal 

separators include decanters. 

d. Cross (tangential) flow filtration 

equipment and ‘‘accessories’’, as follows: 

d.1. Cross (tangential) flow filtration 

equipment capable of separation of 

microorganisms, viruses, toxins or cell 

cultures having all of the following 

characteristics: 

d.1.a. A total filtration area equal to or 

greater than 1 square meter (1 m2); and 

d.1.b. Having any of the following 

characteristics: 

d.1.b.1. Capable of being sterilized or 

disinfected in-situ; or 

d.1.b.2. Using disposable or single-use 

filtration ‘‘parts’’ or ‘‘components’’. 

N.B.: 2B352.d.1 does not control reverse 

osmosis and hemodialysis equipment, as 

specified by the manufacturer. 

d.2. Cross (tangential) flow filtration 

‘‘parts’’ or ‘‘components’’ (e.g., modules, 

elements, cassettes, cartridges, units or 

plates) with filtration area equal to or greater 

than 0.2 square meters (0.2 m2) for each 

‘‘part’’ or ‘‘component’’ and designed for use 

in cross (tangential) flow filtration equipment 

controlled by 2B352.d.1. 

Technical Note: In this ECCN, ‘‘sterilized’’ 

denotes the elimination of all viable microbes 

from the equipment through the use of either 

physical (e.g., steam) or chemical agents. 

‘‘Disinfected’’ denotes a process to reduce the 

number of microorganisms, but not usually of 

bacterial spores, through the use of chemical 

agents, without necessarily killing or 

removing all organisms. 

e. Steam, gas or vapor sterilizable freezedrying equipment with a condenser capacity 

of 10 kg of ice or greater in 24 hours (10 liters 

of water or greater in 24 hours) and less than 

1000 kg of ice in 24 hours (less than 1,000 

liters of water in 24 hours). 

f. Spray-drying equipment capable of 

drying toxins or pathogenic microorganisms 

having all of the following characteristics: 

f.1. A water evaporation capacity of ≥0.4 

kg/h and ≤400 kg/h; 

f.2. The ability to generate a typical mean 

product particle size of ≤10 micrometers with 

existing fittings or by minimal modification 

of the spray-dryer with atomization nozzles 

enabling generation of the required particle 

size; and 

f.3. Capable of being sterilized or 

disinfected in situ. 

g. Protective and containment equipment, 

as follows: 

g.1. Protective full or half suits, or hoods 

dependent upon a tethered external air 

supply and operating under positive 

pressure. 

Technical Note to 2B352.g.1: 2B352.g.1 

does not control suits designed to be worn 

with self-contained breathing apparatus. 

g.2. Biocontainment chambers, isolators, or 

biological safety cabinets having all of the 

following characteristics, for normal 

operation: 

g.2.a. Fully enclosed workspace where the 

operator is separated from the work by a 

physical barrier; 

g.2.b. Able to operate at negative pressure; 

g.2.c. Means to safely manipulate items in 

the workspace; and 

g.2.d. Supply and exhaust air to and from 

the workspace is high-efficiency particulate 

air (HEPA) filtered. 

Note 1 to 2B352.g.2: 2B352.g.2 controls 

class III biosafety cabinets, as specified in the 

WHO Laboratory Biosafety Manual (3rd 

edition, Geneva, 2004) or constructed in 

accordance with national standards, 

regulations or guidance. 

Note 2 to 2B352.g.2: 2B352.g.2 controls any 

isolator having all of the characteristics 

described in 2B352.g.2.a through g.2.d, 

regardless of its intended use and its 

designation, except for medical isolators 

‘‘specially designed’’ for barrier nursing or 

transportation of infected patients. 

h. Aerosol inhalation equipment designed 

for aerosol challenge testing with 

microorganisms, viruses or toxins, as follows: 

h.1. Whole-body exposure chambers 

having a capacity of 1 cubic meter or greater; 

h.2. Nose-only exposure apparatus 

utilizing directed aerosol flow and having a 

capacity for the exposure of 12 or more 

rodents, or two or more animals other than 

rodents, and closed animal restraint tubes 

designed for use with such apparatus. 

i. Spraying or fogging systems and ‘‘parts’’ 

and ‘‘components’’ therefor, as follows: 

i.1. Complete spraying or fogging systems, 

‘‘specially designed’’ or modified for fitting 

to aircraft, ‘‘lighter than air vehicles,’’ or 

‘‘UAVs,’’ capable of delivering, from a liquid 

suspension, an initial droplet ‘‘VMD’’ of less 

than 50 microns at a flow rate of greater than 

2 liters per minute; 

i.2. Spray booms or arrays of aerosol 

generating units, ‘‘specially designed’’ or 

modified for fitting to aircraft, ‘‘lighter than 

air vehicles,’’ or ‘‘UAVs,’’ capable of 

delivering, from a liquid suspension, an 

initial droplet ‘‘VMD’’ of less than 50 

microns at a flow rate of greater than 2 liters 

per minute; 

i.3. Aerosol generating units ‘‘specially 

designed’’ for fitting to the systems as 

specified in paragraphs i.1 and i.2 of this 

ECCN. 

Technical Notes to 2B352.i: 

1. Aerosol generating units are devices 

‘‘specially designed’’ or modified for fitting to 

aircraft and include nozzles, rotary drum 

atomizers and similar devices. 

2. This ECCN does not control spraying or 

fogging systems, ‘‘parts’’ and ‘‘components,’’ 

as specified in 2B352.i, that are 

demonstrated not to be capable of delivering 

biological agents in the form of infectious 

aerosols. 

3. Droplet size for spray equipment or 

nozzles ‘‘specially designed’’ for use on 

aircraft or ‘‘UAVs’’ should be measured using 

either of the following methods (pending the 

adoption of internationally accepted 

standards): 

a. Doppler laser method, 

b. Forward laser diffraction method. 

j. Nucleic acid assemblers and synthesizers 

that are both: 

j.1 Partly or entirely automated; and 

j.2. Designed to generate continuous 

nucleic acids greater than 1.5 kilobases in 

length with error rates less than 5% in a 

single run. 

k. Peptide synthesizers that are both: 

k.1 Partly or entirely automated; and 

k.2 Capable of generating peptides at a 

‘system synthesis scale’ of 1 mmol or greater. 

Technical Note to 2B352.k: ‘System 

synthesis scale’ denotes the maximum 

amount of peptide (mmol) that can be 

produced by the instrument using the largest 

compatible reaction vessels (L). For multiple 

peptides produced in parallel, this is the sum 

of the largest compatible reaction vessels (L). 

N.B. to paragraph .k: See ECCN 2B350 for 

other chemical reaction vessels or reactors. 

* * * * * 

Matthew S. Borman, 

Principal Deputy Assistant Secretary for 

Export Administration. 

[FR Doc. 2024–30425 Filed 12–20–24; 8:45 am] 

BILLING CODE 3510–33–P 


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